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Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound

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ClinicalTrials.gov Identifier: NCT02890277
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Geping Yin, Jinan Military General Hospital

Brief Summary:
Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.

Condition or disease Intervention/treatment Phase
Vulva Intraepithelial Nonneoplastic Device: the high intensity focused ultrasound (Mianyang Sonic electronic LLC) Drug: Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel). Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Nonneoplastic Epithelial Disorders of Skin and Mucosa of Vulva With High Intensity Focused Ultrasound
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Treatment group Device: the high intensity focused ultrasound (Mianyang Sonic electronic LLC)
Drug: Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).



Primary Outcome Measures :
  1. Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology [ Time Frame: One month before treatment and 2,4,6 weeks and 2,6,12,24 monthes after treatment ]
    The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect.



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva).

Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion criteria:

  • atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
  • vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
  • combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
  • other type of cancers that require urgent care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890277


Contacts
Contact: Geping Yin, M.D. 86-0531-51666230 ygpwylll@hotmail.com

Locations
China, Shandong
Jinan Military General Hospital Recruiting
Jinan, Shandong, China, 250031
Contact: Geping Yin, M.D.    86-0531-51666230    ygpwylll@hotmail.com   
Sponsors and Collaborators
Jinan Military General Hospital

Responsible Party: Geping Yin, Professor/Surgeon,Leader of Department of Gynecology, Jinan Military General Hospital
ClinicalTrials.gov Identifier: NCT02890277     History of Changes
Other Study ID Numbers: JNJQ201408
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants